CHU de Nantes
Nantes, France
Not Yet Recruiting
NCT Number: NCT07680504
A Pilot Superiority Study Comparing the Efficacy of a Combination of a Glenohumeral Intra-articular Injection With a Suprascapular Nerve Block Versus a Glenohumeral Intra-articular Corticosteroid Injection in Retractile Capsulitis
Drug Trial
* Single-center * Exploratory trial * Controlled * Randomized * Double-blind * Prospective
Objective is to compare improvements in shoulder function at 3 months between the group receiving an intra-articular injection combined with a suprascapular nerve block and the group receiving an intra-articular injection combined with a placebo block 19 patients in the Experimental Group (block with corticosteroid and intra-articular injection on Day 0) 19 patients in the Control Group (block with saline and intra-articular injection on Day 0)
* Total duration: 36 months * Recruitment period: 24 months * Treatment duration per patient: 2 ultrasound-guided procedures on Day 0 * Follow-up duration per patient: 12 months after the procedure
At J0 : Under ultrasound guidance, inject 2 mL of lidocaine into the notch, then:
* Experimental Group: 8 mL of 1% lidocaine into the notch with 1 mL of betamethasone, * Control Group: 9 mL of saline into the notch.
During these consultations, M1, M3, M6 et M12 , the following examinations will be performed:
* Clinical examination of the painful shoulder, including measurement of range of motion * Visual Analog Scale (VAS) for pain * Quick Dash, OSS, and SPADI self-report questionnaires completed by the patient * Recording of complications * Questions about returning to work
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patients with shoulder pain and stiffness that has persisted for at least 2 months but less than 12 months, with a loss of passive range of motion in at least 2 planes (lateral rotation, medial rotation, abduction, forward flexion) of at least 30 degrees compared to the contralateral side
- Patients between the ages of 18 and 65
- Patients enrolled in a social security program
Exclusion criteria
- - Corticosteroid injection into the affected shoulder < 4 months ago
- History of any surgery on the affected shoulder within the past 12 months
- Patients with a neuromuscular condition (neurological deficit) or shoulder condition (arthropathy) that could interfere with the assessment of the primary endpoint
- Signs or risk of infection (bacterial-like infection and/or fever and/or antibiotic use)
- Poor skin condition of the affected shoulder
- Anticoagulation with VKAs or anti-Xa agents, or active bleeding disorder or one in remission for less than 5 years (malignant hematologic disorders, myelodysplasia, autoimmune thrombocytopenia) or chemotherapy (antiplatelet agents permitted except prasugrel and clopidogrel)*
- Uncontrolled hypertension,
- Decompensated diabetes or diabetes at risk of decompensation,
- Contraindications to diprosten, Kenacort, or lidocaine
- Psychiatric conditions that may be exacerbated by corticosteroids
- Pregnant or breastfeeding women, or women who refuse to use effective contraception
- Individuals belonging to a vulnerable group as defined by Regulation (EU) No. 536/2014 and French law (See section 4.4 of the protocol) - - Patients unable to comply with the protocol requirements (see Section 4.4 of the protocol)
- Patients participating in another clinical research protocol involving a drug or medical device
- Patients who refuse to participate in the study
Treatment and study plan
Diprostene
DrugSupracapsular nerve block: injection of 10 mL of 1% lidocaine (2 mL along the needle path and 8 mL around the nerve), followed by an injection of 1 mL of DIPROSTENE®.
Intra-articular injection: injection of 2 mL of 1% lidocaine along the needle path and 1 mL of KENACORT RETARD® 40 mg.
Saline (0.9% NaCl)
DrugSuprascapular nerve block: Inject 2 mL of 1% lidocaine along the needle path, followed by 9 mL of normal saline.
Intra-articular injection: injection of 2 mL of 1% lidocaine along the needle path and 1 mL of KENACORT RETARD® 40 mg.
Primary outcomes
-
Difference in Quick DASH scores between baseline and M3
Time frame: 3 months
Secondary outcomes
-
1. Functional Assessment
Time frame: D0, Month 1, Month 3, Month 6, month 12
Function using the Quick Dash
-
1. Functional Assessment
Time frame: D0, Month 1, Month 3, Month 6, month 12
Function using the SPADI scores
-
1. Functional Assessment
Time frame: D0, Month 1, Month 3, Month 6, month 12
Function using the OSS
-
Measuring Joint Ranges of Motion with a Goniometer
Time frame: Day 0, Month 1, Month 3, Month 6, and Month 12
-
Pain Assessment
Time frame: D0, Month 1, Month 3, Month 6, month 12
With VAS (Visual Analog Scale) 0-10
-
EVA pain before and after each movement
Time frame: Day 0, Month 1, Month 3, Month 6, and Month 12
-
Return-to-work timelines following the procedure for patients who are employed
Time frame: Month 1, Month 3, Month 6, and Month 12
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Nantes University Hospital
Other
Registry information
Acronym: EBLOUIR
Important dates
- Study start
- 2026
- Primary completion
- 2029
- Study completion
- 2029
- First posted
- Jul 2, 2026
- Registry last updated
- Jul 2, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.